FDA to Research Drug Risk Information on Character Space Limited Social Media

On November 7, 2016, the FDA announced that it intends to conduct research as to whether links can effectively disclose prescription drug risks in character space limited social media content.

This research appears to be another step in the FDA’s efforts to make its rules more accessible to modern communications, such as Twitter. In June 2014, the FDA released its proposed guidance with respect to character space limitations, which effectively limited the amount of product advertising a company can do on platforms where character space is limited. In its guidance, the FDA made clear that lack of character space was not an acceptable reason for failing to provide accurate, balanced product promotion. In fact, the FDA warned companies that some character space limited platforms may not be suitable marketing channels for products that have “complex indications or extensive serious risks” because it may not be possible to present benefit and risk information in a meaningful manner.

In this new proposed research, the FDA will study different medical conditions across different character-space-limited platforms to determine whether risk information is more effectively communicated within the social media content itself or whether a link to the risk information is sufficient. If the studies show that viewers similarly retain and understand risk regardless of whether the risk is communicated within the content itself or through a link, then there is likely to be more pressure on the FDA to allow for different forms of risk communication, even on character space limited platforms.

TIP: Companies with an interest in this study may wish to submit comments to FDA prior to the January 6, 2017 deadline. In the meantime, pharmaceutical and medical device companies promoting regulated products on social media or other character space limited platforms should review such content to confirm compliance with the FDA’s guidelines, including that the advertising includes both the benefits and the risks of the their products.